Uterine manipulator and manipulator tip assembly

Abstract

A disposable uterine manipulator including a pivotable tip support at the distal end of an elongated insertion rod for carrying a manipulator tip assembly, the tip support being rotatable by a manual drive at the proximal end of the insertion rod via a drive linkage to effectuate a range of rotation of the tip support of at least greater than 90° anteversion and at least greater than 30° retroversion. The manual drive may be an articulated linkage, a belt drive, or an axle drive. Several designs for a manipulator tip assembly including a balloon and a dye injection passage are also disclosed.

What is claimed is: 
     
       1. A uterine manipulator, comprising: an elongated insertion rod defining a longitudinal axis and having a proximal end and a distal end;   tip support means pivotally mounted to said distal end of said insertion rod about an axis substantially perpendicular to said insertion rod axis and including means for carrying a manipulator tip assembly thereon;   tip drive means secured to said proximal end of said insertion rod for manual movement by a user of said uterine manipulator;   drive linkage means for transmitting said manual movement of said tip drive means to said tip support means to effect rotation of the latter about said pivot axis over a range of motion of at least about 90° anteverted and at least about 30° retroverted with respect to said insertion rod axis; and   a manipulator tip assembly secured to said tip support, extending therefrom and including a substantially rigid tubular element having an inflatable balloon proximate a free end thereof and lumen means for inflating said balloon.   
     
     
       2. The uterine manipulator of claim 1, wherein said manipulator tip assembly includes a shaft secured to said tip support means. 
     
     
       3. The uterine manipulator of claim 2, wherein said shaft is permanently secured to said tip support means. 
     
     
       4. The uterine manipulator of claim 2, wherein said shaft is round and is press fit into a hexagonal aperture in said tip support means. 
     
     
       5. The uterine manipulator of claim 1, further including an os stop removably placed on said tip support means and about said manipulator tip assembly. 
     
     
       6. A uterine manipulator, comprising: an elongated insertion rod defining a longitudinal axis, having a proximal end and a distal end, and including a longitudinal cavity extending substantially from said proximal end to said distal end;   tip support means disposed in said rod cavity and pivotally mounted to said distal end of said insertion rod about an axis substantially perpendicular to said insertion rod axis and including means for carrying a manipulator tip assembly thereon, said tip support means including slave gear means mounted for rotation about said pivot axis;   tip drive means mounted for rotation about an axis substantially perpendicular to said rod axis and secured to said proximal end of said insertion rod for manual movement by a user of said uterine manipulator, said tip drive means including a knob portion exterior to said rod for grasping by said user to effect said rotation and drive gear means disposed within said rod cavity for rotation responsive to said knob rotation; and   drive linkage means for transmitting said manual movement of said tip drive means to said tip support means to effect rotation of the latter about said pivot axis over a range of motion of at least about 90° anteverted and at least about 30° retroverted with respect to said insertion rod axis, said drive linkage means including a drive belt means run about said drive gear means and extending through said longitudinal cavity to said slave gear means and run thereabout.   
     
     
       7. The uterine manipulator of claim 6, wherein said drive belt means is endless. 
     
     
       8. The uterine manipulator of claim 7, wherein said tip support means include means for maintaining contact of said drive belt means with said slave gear means. 
     
     
       9. The uterine manipulator of claim 6, wherein said tip drive means rotation axis is perpendicular to said tip support means pivot axis. 
     
     
       10. The uterine manipulator of claim 9, wherein said drive belt means is endless, and twists substantially 90° between its run about said drive gear means and its run about said slave gear means. 
     
     
       11. The uterine manipulator of claim 10, wherein said drive gear means and slave gear means include teeth thereon, and said drive belt means includes structure thereon for engagement by said gear means teeth. 
     
     
       12. The uterine manipulator of claim 6, wherein said tip drive means includes means for providing resistance to rotation of said tip support means. 
     
     
       13. The uterine manipulator of claim 12, wherein said resistance means further comprises means for locking said tip drive means against inadvertent movement. 
     
     
       14. The uterine manipulator of claim 6, further including cam surface means on said tip support means for contacting said distal end of said rod and defining at least one extent of said rotational range of motion of said tip support means about said pivot axis. 
     
     
       15. A uterine manipulator, comprising: an elongated insertion rod defining a longitudinal axis, having a proximal end and a distal end, and including a longitudinal cavity extending substantially from said proximal end to said distal end;   tip support means disposed in said rod cavity and pivotally mounted to said distal end of said insertion rod about an axis substantially perpendicular to said insertion rod axis and including means for carrying a manipulator tip assembly thereon, said tip support means including slave gear means mounted for rotation about said pivot axis;   tip drive means mounted for rotation and secured to said proximal end of said insertion rod for manual movement by a user of said uterine manipulator, said tip drive means including a knob portion exterior to said rod for grasping by said user to effect said rotation of said tip drive means; and   drive linkage means for transmitting said manual movement of said tip drive means to said tip support means to effect rotation of the latter about said pivot axis over a range of motion of at least about 90° anteverted and at least about 30° retroverted with respect to said insertion rod axis, said drive linkage means including a drive axle extending longitudinally through said rod cavity from said proximal end to said distal end of said insertion rod and operatively connected to said tip drive means for rotation thereby, and drive gear means at said distal end of said drive axle engaging said tip support means slave gear means.   
     
     
       16. The uterine manipulator of claim 15, wherein said tip drive means is mounted for rotation about an axis substantially perpendicular to said rod axis and further includes drive gear means disposed within said rod cavity for rotation responsive to said knob rotation, and wherein said drive linkage means further includes slave gear means at said proximal end of said insertion rod engaged by said tip drive means drive gear means. 
     
     
       17. A uterine manipulator, comprising: an elongated insertion rod defining a longitudinal axis and having a proximal and a distal end;   tip support means pivotally mounted to said distal end of said insertion rod about an axis substantially perpendicular to said insertion rod axis and including means for carrying a manipulator tip assembly thereon;   tip drive means secured to said proximal end of said insertion rod for manual movement by a user of said uterine manipulator, said tip drive means including a handle extending substantially transverse to said insertion rod and a retractor lever adjacent said handle and pivotally mounted at one end with respect thereto; and   drive linkage means for transmitting said manual movement of said tip drive means to said tip support means to effect rotation of the latter about said pivot axis over a range of motion of at least about 90° anteverted and at least about 30° retroverted with respect to said insertion red axis, said drive linkage means including a drive rod pivotally mounted at one end to said retractor lever between said pivotally mounted end of said retractor lever and a free end thereof, the other end of said drive rod being pivotally secured to said tip support means at a location offset from said pivot axis and about an axis substantially parallel thereto.   
     
     
       18. The uterine manipulator of claim 17, further including locking pawl means extending between said handle and said retractor lever for providing resistance to rotational movement of said tip support means. 
     
     
       19. The uterine manipulator of claim 18, wherein said insertion rod, said handle, said retractor lever, said locking pawl and said drive rod comprise a single molded plastic unit, and said pivotal mounts of said retractor and said drive rod to said retractor lever comprise flexible areas of reduced material cross section. 
     
     
       20. A uterine manipulator, comprising: an elongated insertion rod defining a longitudinal axis and having a proximal end and a distal end;   tip support means pivotally mounted to said distal end of said insertion rod about an axis substantially perpendicular to said insertion rod axis and including means for carrying a manipulator tip assembly thereon;   tip drive means secured to said proximal end of said insertion rod for manual movement by a user of said uterine manipulator;   drive linkage means for transmitting said manual movement of said tip drive means to said tip support means to effect rotation of the latter about said pivot axis over a range of motion of about 120° anteverted and about 70° retroverted with respect to said insertion rod axis; and   a manipulator tip assembly secured to said tip support, extending therefrom and including a substantially rigid tubular element having an inflatable balloon proximate a free end thereof and lumen means for inflating said balloon.